Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Metabolic Syndrome Clinical Trial

Official title:

Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04893226
• Other study ID #: BIO-21-TRF
• Secondary ID: 1R01DK124774-01A
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2021
• Est. completion date: February 27, 2026

Study information

• Verified date: November 2023
• Source: University of Kentucky
• Contact: Matt Thomas, PhD
• Phone: (859) 218-6770
• Email: jmthomg[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.

Description:

This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding (TRF) on metabolic risk in postmenopausal women. Data will be collected for 18 weeks. Baseline food timing, activity/sleep, and metabolic parameter (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers) data will be collected in the first two weeks (baseline). Subjects will then be randomized to the TRF intervention or no TRF for 16 weeks. Subjects in the TRF group will be educated about the health benefits of TRF. Then each subject in the TRF group will self-select a 10-h window and consume all daily calories during this time frame. Subjects in both the TRF and no TRF groups will text the time of their first and last daily meals for the duration of the study. At the end of the 16-week TRF intervention or no TRF, metabolic and anthropometric measurements will be collected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: February 27, 2026
• Est. primary completion date: February 27, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• postmenopausal women
• age 45-65 years
• prediabetic or have at least 2 features of metabolic syndrome

Exclusion Criteria:

• on hormone therapy
• diabetes
• heart disease
• alcohol consumption of >2 drinks per day
• significant circadian disruption
• having care-taking responsibilities that significantly affect sleep
• shift work or irregular lifestyle
• uncontrolled sleep apnea or sleep disorder
• extreme early or late chronotypes
• significant psychiatric disorders or ADHD
• diagnosed dysregulated eating behaviors

Related Conditions & MeSH terms

• Metabolic Syndrome
• Postmenopausal Symptoms

Intervention

Behavioral:
• Time-Restricted Feeding (TRF)
Subjects will be educated about the health benefits of time-restricted feeding (TRF). Each subject in the TRF group will self-select a 10 hour (10h +/- 1hr) window aligned with their active phase during which they will consume all daily calories. Subjects will text the time of their first and last daily meals for the duration of the study.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Julie Pendergast	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insulin Sensitivity	Matsuda index will be assessed by the oral glucose tolerance test (OGTT).	18 weeks (baseline and post-intervention)
Primary	Change in Body Mass Index	Body mass index will be calculated from height and weight.	18 weeks (baseline and post-intervention)
Primary	Change in Triglycerides	Triglycerides will be measured from fasting blood	18 weeks (baseline and post-intervention)
Secondary	Change in Hemoglobin A1c	HbA1c is a measure of the proportion of glycated hemoglobin in blood.	18 weeks (baseline and post-intervention)
Secondary	Change in C-Reactive Protein	CRP will be measured from blood samples.	18 weeks (baseline and post-intervention)
Secondary	Change in Mid-sleep	Mid-sleep is a single outcome calculated using both actigraphy and sleep log information.	18 weeks (baseline and post-intervention)
Secondary	Change in Sleep Fragmentation Index	Sleep fragmentation index, a measure of sleep quality, will be assessed from actigraphy data.	18 weeks (baseline and post-intervention)